IDB-011 Safety Study

Overseen By Main Contact

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: IDBiologics, Inc.

Disqualifiers: RVFV infection, Malignancy, Cardiovascular, HIV, others

Compensation: Varies

Number of Visits: 4

Duration: 4 days

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and response of a new treatment called IDB-011, an experimental treatment administered as a muscle injection at different dose levels. It aims to assess how the body processes the treatment and identify any side effects, using a placebo (a harmless, inactive substance) for comparison. The trial seeks healthy adults who are non-smokers, not pregnant, and willing to avoid alcohol and caffeine shortly before and during the study. Participants should also have no history of certain diseases or recent vaccinations. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the unique opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for healthy participants and has strict eligibility criteria, it's possible that you may need to pause certain medications. Please consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that IDB-011 is likely to be safe for humans?

Research shows that IDB-011 is undergoing testing for safety and tolerance in healthy adults. This marks the first time IDB-011 has been tested in humans, so information about its safety remains limited. As a Phase 1 trial, the primary goal is to assess the treatment's safety for people.

Researchers closely monitor participants for any side effects or problems, allowing for early detection of issues. While specific side effects for IDB-011 are not detailed, Phase 1 studies involve only a small number of participants to minimize risk. If IDB-011 presented serious safety concerns, it would not progress to further studies. So far, no major safety issues have been reported, which is encouraging. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about IDB-011 because it offers a potentially novel approach to treating conditions where current treatments may fall short. Unlike typical therapies that might rely on well-known pathways, IDB-011 is designed with a unique mechanism of action that targets specific underlying processes more precisely. This could mean better outcomes for patients who haven't responded well to existing options. Additionally, the study is exploring different dosage levels of IDB-011, which may help identify the most effective and safe dose, offering a tailored treatment solution.

What evidence suggests that IDB-011 could be effective?

Research shows that IDB-011 consists of two parts, IDB-774 and IDB-898, designed to work together to support the immune system. Although limited human data exists on IDB-011's effectiveness, it appears to aid the body in fighting infections. Earlier studies have found that treatments with two components like this can enhance immune system function. This is promising because a strong immune system is crucial for preventing or managing infections. However, more information is needed to determine its effectiveness for specific health issues. Participants in this trial will receive varying doses of IDB-011 or a placebo to assess its safety and effectiveness. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for healthy adults who can participate in a study testing the safety of different doses of IDB-011, a potential treatment for infections like Coccidioidomycosis and Rift Valley Fever. Specific eligibility criteria are not provided.

Inclusion Criteria

I am a healthy male or female.

Agree to not donate blood or plasma during study participation

Body mass index (BMI) within 18.0 kg/m2 to 30.0 kg/m^2, inclusively

Exclusion Criteria

History of hypersensitivity reaction

I haven't received any vaccines in the last 28 days.

I have had a Rift Valley fever virus infection before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single ascending doses of IDB-011 or placebo via intramuscular injections

4 days

In-patient stay for up to 4 consecutive days

Follow-up

Participants are monitored for safety, pharmacokinetics, and immunogenicity

1 year

What Are the Treatments Tested in This Trial?

Interventions

• IDB-011

Trial Overview The trial is assessing various dose levels (1 to 5) of IDB-011 compared to a placebo. It's designed as a Phase 1 study where participants receive one-time intramuscular injections in increasing amounts to evaluate how safe it is and how the body processes it.

How Is the Trial Designed?

Group I: Experimental: IDB-011 Cohort 5 Experimental Treatment 1 Intervention

IDB-011 dose level 5

Group II: Experimental: IDB-011 Cohort 4 Experimental Treatment 1 Intervention

IDB-011 dose level 4

Group III: Experimental: IDB-011 Cohort 3 Experimental Treatment 1 Intervention

IDB-011 dose level 3

Group IV: Experimental: IDB-011 Cohort 2 Experimental Treatment 1 Intervention

IDB-011 dose level 2

Group V: Experimental: IDB-011 Cohort 1 Experimental Treatment 1 Intervention

IDB-011 dose level 1

Group VI: Comparator: Placebo Placebo Group 1 Intervention

Normal saline

Who Is Running the Clinical Trial?

IDBiologics, Inc.

Lead Sponsor

Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies

Collaborator

Trials

3

Recruited

1,000+

Published Research Related to This Trial

MetaADEDB 2.0 is an updated online database that now includes 744,709 drug-adverse drug event (ADE) associations, representing a 40% increase from its previous version, making it a more comprehensive resource for researchers.

The new version features a user-friendly web interface, enhancing accessibility for drug safety assessments and studies in drug discovery and development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MetaADEDB 2.0: a comprehensive database on adverse drug events. Yu, Z., Wu, Z., Li, W., et al.[2021]

The recent fatal adverse event in the BIA-102474-101 clinical trial highlights significant limitations in the current safety review process for first-into-human trials, despite previous trials with similar compounds being conducted without incident.

To improve safety in future trials, it is crucial to implement sequential dosing strategies, thorough reviews of preclinical toxicity studies, and systematic risk assessments, especially for novel compounds that may pose higher risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implications of the BIA-102474-101 study for review of first-into-human clinical trials. Eddleston, M., Cohen, AF., Webb, DJ.[2021]

The safety of marketed drugs is a significant concern, as some commonly prescribed medications can lead to serious or life-threatening side effects in patients.

The ChEMBL resource will provide a curated drug safety data set, including toxicity classifications and black box warnings, which will be freely available and regularly updated to aid in drug safety research and discovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. Hunter, FMI., Bento, AP., Bosc, N., et al.[2023]

The DIMDI provides comprehensive databases that contain valuable information on adverse drug reactions, which can help healthcare professionals and researchers understand the safety profiles of various medications.

Access to these databases is crucial for monitoring drug safety and improving patient care by identifying potential risks associated with drug treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Information on adverse drug reactions in databases hosted at the German Institute of Medical Documentation and Information (DIMDI)]. Bystrich, E.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06925919

NCT06925919 | Study to Evaluate Safety, Tolerability and ... A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety Tolerability and Pharmacokinetics of IDB-011 (IDB-774+IDB-898) in Healthy Adults.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06925919?cond=%22Coccidiosis%22&viewType=Table&rank=1

NCT06925919 | Study to Evaluate Safety, Tolerability and ... A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety Tolerability and Pharmacokinetics of IDB-011 (IDB-774+IDB-898) in Healthy Adults.

3. withpower.com withpower.com/trial/phase-1-coccidioidomycosis-3-2025-1f904

IDB-011 Safety Study The MetaADEDB 2.0 database provides comprehensive information on adverse drug events, which can be useful for assessing the safety of treatments like IDB-011.

4. synapse.patsnap.com synapse.patsnap.com/organization/bef37b6eaa8b75be7afdd366d1bf8709

IDBiologics, Inc. - Drug pipelines, Patents, Clinical trials A randomized, double-blind, placebo-controlled study to assess the safety tolerability and pharmacokinetics of IDB-011 (IDB-774+IDB-898) in healthy adults.

5. trial.medpath.com trial.medpath.com/clinical-trial/ffb11879c1fc0d84/nct06925919-idb-011-safety-tolerability-pharmacokinetics

Study to Evaluate Safety, Tolerability and Pharmacokinetics of ... Phase 1 randomized, double-blind, placebo-controlled trial to evaluate safety, tolerability, pharmacokinetics (PK) and immunogenicity of IDB-011 following ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/condition/66/fungal-infections

Fungal Infections Clinical Research Trials Study to Evaluate Safety, Tolerability and Pharmacokinetics of IDB-011. This is a randomized, double blind, placebo-controlled, dose escalation, first-in-human, ...